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Recruiting Phase 3 NCT06615102

Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II

Trial Parameters

Condition Cardiac Surgery
Sponsor Universität Münster
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,022
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-31
Completion 2027-01
Interventions
Angiotensin IINoradrenalin

Brief Summary

The study intervention focuses on exploring the use of angiotensin II as a primary vasopressor compared to norepinephrine in cardiac surgery patients to investigate whether angiotensin II can reduce the occurrence of moderate/severe acute kidney injury (AKI). Despite its potential, as suggested by trials involving surgical patients, there is currently no human data confirming its effectiveness in preventing moderate/severe AKI in this context. The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.

Eligibility Criteria

Inclusion Criteria: 1. Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery 2. Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale: 1. hemoglobin \< 130g/l = 2 2. creatinine \> 1.1 mg/dl = 2 3. age \> 70 years =1.5 4. New York Heart Association Classification (NYHA) 4 =1.5 5. Body Mass Index (BMI) \> 30 =1.5 3. Adult ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement 2. Already receiving inotropic/vasopressor support before surgery 3. Dialysis dependent 4. Pre-existing AKI within the last 30 days 5. Pre-existing chronic kidney injury with an eGFR\<20 ml/min/1.73m2 6. Pre-existing significant hypertension (persistent SBP \> 180mmHg) 7. Significant pulmonary hypertension (ePSAP \> 70mmHg, mPAP \> 40mmHg) with right ventricular

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